Syndrome X is a metabolic condition characterized by the presence of several of the following risk factors: hyperglycemia, hypertension, low high-density lipoprotein (HDL), high low-density lipoprotein (LDL), high triglyceride, and abnormal body mass index (BMI), micro-albuminuria, endothelial dysfunction, pro-thrombotic state, and inflammatory process. Although not all these criteria need to be met before a diagnosis of the disease may be found. In fact, three occurrences of these symptoms may be found indicative of the disease.
It is estimated that over 22% of the adult U.S. population have Syndrome X and the incidence is rapidly increasing each year. Old age, postmenopausal status, ethnicity, higher body mass index, current smoking, low household income, high carbohydrate intake, and physical inactivity all have been connected with the increased odds of the onset and or deterioration of Syndrome X. An additional 12 million adults will likely develop the condition as a result of aging alone by 2022.
Not a single cause at the molecular level can be traced to the origin of Syndrome X. However, increasing evidence suggests the condition originates from both insulin resistance and activation of vascular inflammatory mechanisms related to increased oxidative stress. For example, insulin resistance results in preferential metabolism of free fatty acids which leads to reduced glucose utilization. Insulin resistance is identified in children prior to the development of the dyslipidemia, hypertension and hyperglycemia that occur later in life. As one ages, pancreatic beta cell exhaustion is not able to meet insulin resistance demands, and this might eventually lead to the progression of metabolic disturbance including dyslipidemia, hypertension, etc. On the other hand, the infiltration of adipose tissue by inflammatory macrophages has been indicated as a common feature of obesity. Adipose mass correlates quantitatively with genetic expression of macrophages that produce inflammatory mediators and markers. Therefore, while Syndrome X may share some characteristic features with diabetes, it is not a diabetic or pre-diabetic condition per se. Other distinct factors and causes are also involved.
All in all, the treatment for Syndrome X varies greatly. Many times, a person diagnosed with several risk factors as discussed above would be prescribed a low fat diet, exercise regime, and pharmaceutical intervention including a host of drugs to individually combat issues with cholesterol, blood pressure, glucose, and body weight. Due to the complicated nature of such therapy, often times compliance is rather low.
Cinnamon is known in the art for the control of blood glucose. Broadhurst et al. demonstrated that cinnamon is a strong potentiator of insulin in comparison to various other herbs and spices (J. Agric. Food Chem., 2000; 48:849-852). Researchers have demonstrated that cinnamon's glucose-lowering effects are from a class of compounds other than chromium. One study by Kahn et al. compared the chromium levels of foods and spices including cinnamon, and failed to find a correlation between chromium level and the level of insulin potentiation (Biological Trace Element Research, 1990; 24: 183-188). A meta-analysis by Althuis et al. showed no association between chromium and glucose or insulin concentration (Am. J. Clin. Nutr., 2002; 76: 148-55).
In a more recent study by Khan et al. (Diabetes Care, 2003, 26, 3215-3218), type II diabetes patients were found to have their glucose and lipid profile improved after cinnamon intake. These patients were of age 40 and above with glucose levels in the range of 140-400 mg/dL. Daily treatment with cinnamon reduced fasting glucose levels by 18-29% in these patients, as well as triglycerides by 23-30% and LDL by 7-27%. It is noted that these patient were “very diabetic” when recruited for the study. Although rendered “less diabetic” after the cinnamon treatment, these patient were still diabetic with abnormally high blood glucose levels. So it remains to be determined whether the raw cinnamon regime as prescribed in this study would be effective to reverse these patients' glucose level from an abnormal state to a normal state, as defined by NCEP-ATP-III. In addition, another important biomedical parameter, lean body mass, was not examined in this study.
Therefore, and in view of the fact that Syndrome X is distinguishable in cause and effect from diabetes, these prior art disclosures do not teach a treatment for pathological states such as hypertension and hyperglycemia in subjects who are not already diabetic; nor do they support a method to concurrently reduce and improve three or more risk factors associated with the Syndrome X even in diabetic subjects. Furthermore, these prior art documents fail to provide a useful teaching on how to eliminate a risk factor or reverse a disease state, for example, to render the subject from being diabetic to non-diabetic.
To date, the prior art has not provided any therapeutic materials which can specifically address Syndrome X. Heretofore, therapies have been directed to the treatment of specific features of the syndrome on an individual basis, and not to any holistic therapy. As will be explained in detail, the present invention recognizes that particular cinnamon-derived materials are effective in simultaneously controlling multiple pathologies of Syndrome X. Furthermore, the therapeutic materials and methods hereof are simple to implement and conducive to good patient compliance.